Group 1 - Intra-Cellular Therapies, Inc. announced the appointment of Sanjeev Narula as Executive Vice President and Chief Financial Officer, effective August 12, 2024 [1] - Lawrence Hineline, the current CFO, will retire on the same date but will remain as a consultant to ensure a smooth transition [1] - Dr. Sharon Mates, the CEO, expressed excitement about Mr. Narula's extensive experience in large commercial stage pharmaceutical companies, highlighting his strategic and operational expertise [2] Group 2 - Mr. Narula has significant experience in the pharmaceutical industry, having served as CFO of Viatris since its formation in 2020, and previously held various financial leadership roles at Pfizer [3] - His background includes overseeing finance, procurement, and business technology at Upjohn, and he has held positions at American Express and Xerox India [3] - Mr. Narula holds a bachelor's degree in commerce (honors) from Delhi University and is a Chartered Accountant [3] Group 3 - Mr. Narula expressed his honor in joining Intra-Cellular Therapies and his eagerness to contribute to the company's growth strategy, particularly in building on the commercial success of CAPLYTA and advancing its pipeline [4] - Intra-Cellular Therapies focuses on developing innovative treatments for complex psychiatric and neurologic diseases, based on Nobel prize-winning research [5]

NEW YORK, Aug. 07, 2024 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (Nasdaq: ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced that Sanjeev Narula will join the Company on August 12, 2024 and will serve as Executive Vice President, Chief Financial Officer. Mr. Narula will report to Dr. Sharon Mates, ITCI's Chairman and Chief Executive Officer. Lawrence Hineline, who currently serves as Chief ...

CAPLYTA Q2 2024 net product sales were $161.3 million, compared to $110.1 million for the same period in 2023, representing a 46% increase CAPLYTA's strong prescription uptake continues: Q2 2024 CAPLYTA total prescriptions increased 36%, versus the same period in 2023 CAPLYTA 2024 net product sales guidance raised to $650 to $680 million Announced positive Phase 3 results from Study 501 and Study 502 evaluating lumateperone as an adjunctive therapy to antidepressants in patients with major depressive disord ...

CAPLYTA Q2 2024 net product sales were $161.3 million, compared to $110.1 million for the same period in 2023, representing a 46% increase CAPLYTA's strong prescription uptake continues: Q2 2024 CAPLYTA total prescriptions increased 36%, versus the same period in 2023 CAPLYTA 2024 net product sales guidance raised to $650 to $680 million Announced positive Phase 3 results from Study 501 and Study 502 evaluating lumateperone as an adjunctive therapy to antidepressants in patients with major depressive disord ...

Core Insights - Intra-Cellular Therapies, Inc. will host a conference call and live webcast on August 7, 2024, to provide a corporate update and discuss financial results for the quarter ended June 30, 2024 [1] Company Overview - Intra-Cellular Therapies is a biopharmaceutical company focused on developing therapeutics for central nervous system disorders, leveraging Nobel prize-winning research to understand cellular mechanisms [4] - The company aims to create innovative treatments for complex psychiatric and neurologic diseases [4]

Year to date, shares of Intra-Cellular have gained 6.9% against the industry's 5.8% decline. Please note that the company is simultaneously evaluating lumateperone for several other indications. The most prominent of the additional indications being pursued for the drug is major depressive disorder (MDD). In the first half of 2024, the company reported achieving the primary and key secondary efficacy endpoints in two global phase III studies, 501 and 502, evaluating 42 mg of lumateperone as an adjunctive th ...

Core Insights - Intra-Cellular Therapies (ITCI) announced positive top-line results from Study 502, the second late-stage study evaluating lumateperone 42 mg for major depressive disorder (MDD) [1] - The study achieved statistically significant and clinically meaningful results in both primary and key secondary endpoints, indicating the drug's effectiveness [4][11] Study Results - Study 502 demonstrated a statistically significant reduction in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score compared to placebo at week six [11] - The key secondary endpoint showed a significant reduction in the Clinical Global Impression Scale score at week six [2] - Improvement in depressive symptoms was also noted through the Quick Inventory of Depressive Symptomatology Self Report (QIDS-SR-16) [3] Safety Profile - Lumateperone was generally safe and well-tolerated, with most adverse events being mild to moderate in severity [6] - Safety data from Study 502 aligns with previous studies of lumateperone for MDD, bipolar depression, and schizophrenia [6] Regulatory and Market Implications - The success of Studies 501 and 502 supports a regulatory filing for label expansion of lumateperone as an adjunctive treatment for MDD, anticipated in the second half of 2024 [14] - If approved, the eligible patient population for Caplyta will expand, potentially boosting revenues for the company [22] Market Performance - Following the announcement of positive results, ITCI's stock climbed 9.6% on June 18, with a year-to-date gain of 5.4% compared to the industry's 7.1% decline [15]

Company Overview - Intra-Cellular Therapies (ITCI) shares increased by 9.6% to close at $75.48, with notable trading volume compared to typical sessions, and a 5.4% gain over the past four weeks [1] - The company is expected to report a quarterly loss of $0.20 per share, reflecting a year-over-year change of +55.6%, with anticipated revenues of $157.59 million, up 42.2% from the previous year [2] Earnings Estimates - The consensus EPS estimate for the upcoming quarter has been revised 2.6% lower over the last 30 days, indicating a negative trend in earnings estimate revisions, which typically does not lead to price appreciation [3][6] - The stock currently holds a Zacks Rank of 3 (Hold) [7] Industry Context - Intra-Cellular operates within the Zacks Medical - Biomedical and Genetics industry, where EyePoint Pharmaceuticals (EYPT) closed 3.6% lower at $8.69, with a -25.8% return over the past month [4] - The recent surge in ITCI's stock price followed the announcement of statistically significant results in late-stage studies for lumateperone 42 mg, aimed at treating major depressive disorder (MDD) [5] Future Prospects - The success of both phase III studies forms the basis for a regulatory filing to expand the label of lumateperone as an adjunctive treatment for MDD, with a supplemental new drug application anticipated in the second half of 2024 [5]

Lumateperone 42 mg met the primary endpoint of change from baseline at Week 6 on the Montgomery-Åsberg Depression Rating Scale (MADRS) total score versus placebo (4.5 point reduction v. placebo; p<0.0001; Cohen's d effect size (ES)=0.56) Statistically significant efficacy was also seen in the Quick Inventory of Depressive Symptomatology SelfReport (QIDS-SR) scale, a patient self-reported measure of symptom severity of depression (p<0.0001) Supplemental NDA (sNDA) submission for the adjunctive treatment of m ...

The live and archived webcast can be accessed under "Events & Presentations" in the Investor Relations section of the Company's website at www.intracellulartherapies.com. Please log in approximately 5-10 minutes prior to the event to register and to download and install any necessary software. Burns McClellan, Inc. Cameron Radinovic cradinovic@burnsmc.com 646-930-4406 Intra-Cellular Therapies is a biopharmaceutical company founded on Nobel prize-winning research that allows us to understand how therapies af ...